Safety Alert Resource Center
HRS Therapy Advisory Working Group
The field of cardiac electrophysiology relies on technological advances that improve patients' lives. However, there are also EP device software/hardware updates, safety notices, advisories, and recalls that occur from time to time.
Therefore, in 2014, HRS created the Therapy Advisory Working Group, which convenes on an as-needed basis, to review any EP device -related advisory issue or safety notification that may affect our HRS members and their patients.
The goals of the Working Group are to review these advisory or safety issues and to communicate with our HRS members in a timely manner in order to enhance awareness of these issues in the EP community.
HRS will continue to work closely with our industry partners and federal regulatory agencies in a collaborative, interactive manner in order to provide our membership with clear, accurate information concerning EP device advisories and other safety issues. The Therapy Advisory Working Group aims to provide concise, useful information (and recommendations when appropriate) without excessively burdening clinicians as these safety issues arise.
Reporting Adverse Events
The Heart Rhythm Society encourages healthcare professionals and patients to report adverse events or product problems to FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. There are several options for reporting:
- Complete and submit the report online
- Download MedWatch Online Voluntary Reporting Form
- Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Software Update for LifeVest 4000 Wearable Cardioverter Defibrillator -(01/15/2019) The FDA approved a new software for the ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code 102” is displayed. The potential hazard of the device failing to deliver treatment to a patient if the device is not replaced soon after displaying a “Call for service – Message Code 102” was previously described in the January 17, 2018 FDA Safety Communication and an update on July 25, 2018. The Zoll guidance to health care professional can be found at: https://lifevest.zoll.com/fdacomm/ . Learn more
Safety Advisory: Boston Scientific first generation S-ICD - (11/06/2018) On November 5, Boston Scientific released a product advisory related to accelerated battery depletion and a shortened replacement interval observed in some of the first generation Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system SQ-RX™ Model 1010 Pulse Generators (PG) (acquired from Cameron Health Incorporated). There have been no reports of related injury. This safety risk is not applicable to the EMBLEM™ MRI or EMBLEM S-ICD. Learn more
Safety Advisory Regarding Medtronic Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan Pacemakers - (7/02/2018) On June 22, Medtronic released a software update to prevent possible device reset to RV only pacing at 65 bpm for the Percepta family of CRT pacemakers. Due to a potential timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP) of the Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan, Medtronic has determined that certain devices may revert to RV-only VVI pacing at 65 bpm. Approximately 7,803 devices in the USA are affected. Learn more
Safety Advisory Regarding Medtronic EnTrust ICDs - (6/21/2018) Medtronic announced an urgent medical device recall affecting approximately 2,770 (209 confirmed active in the U.S.) EnTrust ICDs due to the potential for loss of high voltage and ATP therapy as they near elective replacement indicator (ERI) stage. This model was last manufactured in 2010. Twenty-five devices have experienced a charge time out due to reaching End of Life (EOL) with no (21) or abbreviated (4) ERI stage. To date, there have been no patient deaths or complications due to this issue. Learn more
Abbott Advisory Regarding Battery Performance and Firmware Update - (4/18/2018) The US Food and Drug Administration (FDA) issued a Medical Device Safety Communication announcing a firmware update that addresses 2 previously reported safety concerns. The update includes a battery performance alert and improved cybersecurity for certain high voltage implantable cardiac devices (ICDs and CRT-Ds). Learn more
Medtronic Extends Voluntary Recall to Include 752 ICDs and CRT-D Units Due to Lack of Electrical Shock Delivery - (3/19/2018) n March 16, Medtronic announced a voluntary recall affecting 752 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs). This notification extends the Food and Drug Administration (FDA) recall on February 26, 2018of 48 Medtronic devices that were identified to have a defect in the manufacturing process that could lead to an out-of-specification internal gas environment. Learn More
Medtronic Recalls 48 Individual ICDs and CRT-D Units Due to Lack of Electrical Shock Delivery - (2/28/2016) The Food and Drug Administration (FDA) announced a recall of 48 individual Medtronic ICDs and CRT-Ds, identified by the devices' serial numbers. For these 48 individual units, the Class I recall recommends that the physician and the patient strongly consider prophylactic device replacement for patients who have been implanted with one of the affected devices. Learn more
Abbott: Battery Performance Alert for ICDs- (08/29/17) - Abbott has released a new Battery Performance Alert (BPA), that provides an earlier notification of abnormal battery performance that may lead to premature battery depletion due to short circuits from lithium clusters. The software patch is available on the St. Jude Programmer and on Merlin.net. Learn more
Abbott Cybersecurity Advisory- (08/29/17): On August 29, Abbott and the Food and Drug Administration each released a public safety communication regarding the availability of a pacemaker software patch to address a cybersecurity risk. The identified risk could allow unauthorized access to pacemakers that utilize radio frequency (RF) communications. Learn more
FDA Warning Letter to Abbott (St Jude Medical Inc.)- (04/17/2017)- On April 12th, 2017 the U.S. Food and Drug Administration (FDA) issued notification to Abbott (St Jude Medical Inc.) that they were in violation of 4 codes of federal regulations (CFRs). This notification was part of the enforcement phase of the FDA’s ongoing investigation of issues with Abbott’s (St Jude Medical Inc.) ICD pulse generators and transmitters. Learn more
St. Jude Merlin@home Transmitter (01/09/2017) - The US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) issued a safety communication regarding a cybersecurity vulnerability of the St. Jude Merlin@home Transmitter. Learn more
Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices (10/11/2016)- On October 11 2016, the U.S. Food and Drug Administration issued a safety communication alerting health care providers and patients about premature battery depletion in a subset of St. Jude Medical ICD and CRT-D devices. Learn more